Summary
The Director, MSAT Operations is responsible for all product and process transfer activities at the CDMO level (inbound, outbound, and within), including scale-up, industrialization, and other process adaptations. This role will collaborate with the technical transfer project teams at CDMO sites and serve as a liaison between internal ARTBIO and external CDMO functions (e.g., Generator and CMC Development, Supply Chain, Production Unit, Quality Control, HSE, etc.).
This role is critical in scaling complex generator use, radiolabeling, synthesis, and aseptic filling operations following acceptance from R&D, as well as CMC (i.e., process validation and initial batches). The Director, MSAT Operations will lead the transition to commercial readiness and global [JL1] expansion of the technology. This role will lead the technical and industrialization aspects of new production lines and/or site builds, ensuring facilities are designed and commissioned to meet the stringent requirements of radiopharmaceutical production, in line with radiation safety, containment, and regulatory compliance standards.